Devices

Endovascular Today published an article in July 2014 in which three doctors well-versed in dealing with inferior vena cava (IVC) filters were interviewed for their opinions on indications, patient follow-up & retrieval rates and the prophylactic use of the devices. The three interviewees were:
• Dr. William T. Kuo, MD, FSIR, FCCP FCIRSE; Director, Interventional Radiology at Stanford University Medical Center, Stanford, California
• Dr. Gerard Goh, MD, EBIR; Consultant Interventional & Diagnostic Radiologist at The Alfred Hospital in Melbourne, Australia
• Dr. Frank Arko, MD; Vascular and Endovascular Surgery at Sanger Heart and Vascular Institute in Charlotte, North Carolina

Guidelines for using IVC Filters
The interviewees were questioned as to what guidelines they and their respective facilities followed re: implanting IVC filters. Their answers point to a problem in the field: namely, that there isn’t one uniform set of guidelines for IVC filter use and that they differ across the board.

Dr. Goh employs his facility’s local guidelines. These are based upon the Cardiovascular and Interventional Radiological Society of Europe’s (CIRSE) “quality improvement guidelines” for IVC filter use. These guidelines essentially indicate IVC use is proper in patients with:
• Pulmonary embolism (PE), a dangerous condition involving a blood clot that could reach the lungs, potentially causing death
• Deep-vein thrombosis (DVT), another dangerous condition in which the clots form in the deep veins, typically in the legs
• History of complications from anticoagulant (blood thinning) therapy or in whom such therapies are either ineffective or contraindicated
• Severe trauma
• Poor patient compliance with anticoagulant therapy
• Free-floating iliofemoral or IVC clots.

Dr. Arko follows different guidelines based upon those of the Society of Interventional Radiology (SIR). His facility only implants IVC filters when there are contraindications to blood thinning therapies or such therapies cause complications or simply don’t work. Dr. Arko’s facility doesn’t use IVC filters in trauma patients, however he knows of prophylactic use in severe trauma cases, such as closed head injuries, spinal cord injuries and long bone or pelvic fractures.

Dr. Kuo and his facility are perhaps the most cautious in their use of IVC filters. He cites various published guidelines, such as those from the American College of Chest Physicians (ACCP), the American Heart Association (AHA), the Eastern Association for the Surgery of Trauma (EAST) and SIR. Dr. Kuo said the most recent and often updated guidelines come from the ACCP. However, the most important factor for Dr. Kuo in deciding to use an IVC filter is based on the PREPIC study.

Follow-up & Removal
IVC filters were not intended to be permanent implants. However, at least in the U.S., there is a huge percentage of patients (66% in 2014) who still have their IVC filters long after the risk of PE has passed. The FDA has issued two safety alerts recommending that IVC filters be removed once the risk of PE has passed.

According to Dr. Kuo, the medical literature as well as the FDA’s MAUDE database for adverse event reporting clearly shows that the longer an IVC filter remains in place after the risk of PE has passed, the greater the risk for serious, potentially fatal, complications. In fact, Dr. Kuo and Stanford developed a follow-up protocol for those patients who only need the temporary type of IVC filter device.

Their patients are automatically scheduled for a return visit for removal “within a few months after successful therapeutic anticoagulation has been achieved and once the risk of PE has diminished.” If the IVC filter is still necessary following that appointment, the clinic closely monitors patients and brings them in for removal once the conditions are met. This is accomplished via the clinic’s in-house FILTER registry.

Dr. Kuo has become the “go-to” surgeon for removal of IVC filters that have been left in too long. He and his team have set up the Stanford IVC Filter Clinic, the purpose of which is to help patients who are not necessarily Stanford Medical Center patients, but who have developed complications with their filters that make standard retrieval almost impossible. The Clinic receives referrals from across the country.

Likewise, Dr. Goh’s facility uses an in-house registry, recording all IVC filter implants and projected dates for removal. A removal appointment is typically set for six weeks post-implant and most of their patients undergo removal surgery at that appointment or a later rescheduled time. The clinic also calls patients who don’t keep their removal appointments and focuses on educating them about the need for prompt removal.

Dr. Arko’s removal protocol has patients return four weeks post-implant for a removal assessment. He said their follow-up is very good “due to the fact that we really do not have any trauma patients in our practice.”

Prophylactic Use of IVC Filters
There is a trend in the U.S. to implant IVC filters in certain patient populations as a prophylactic or preventative measure, even when there is no history of PE or DVT. Such populations typically include those undergoing high-risk surgery like spinal or bariatric procedures. None of the doctors felt that enough evidence existed to support such widespread prophylactic use of the devices.

In fact, Dr. Arko said, “I personally try to limit the use of prophylactic filters.” Dr. Goh is of the opinion that, while such use lowers the occurrence of PE, it increases the risk of DVT and, as such, may not be the best choice.

Dr. Kuo agreed. His practice doesn’t typically implant prophylactic IVC filters in trauma patients without a history of venous thromboembolism (VTE), a condition involving both DVT and PE. He said that most trauma patients don’t get the high level of follow-up necessary to ensure prompt removal, which opens them to greater complications in the future. He currently cooperates with Stanford’s bariatric surgery department if they request the implantation of a prophylactic IVC filter. However, he is considering stopping the practice as data showed “little benefit and perhaps significant risks associated with prophylactic IVC filters among bariatric surgery patients.”

The bottom line is that prolonged use of IVC filters presents the majority of patients with an increased risk of serious, potentially life-threatening complications. There are few, if any, long-term use benefits, especially when compared to these risks, which include:
• Migration of the IVC filter, including to another blood vessel (called embolization)
• Fracture of the filter
• Penetration of the inferior vena cava by the filter
• IVC perforation of the inferior vena cava
• IVC thrombosis (a clot forming around the filter)

In an article published in the International Journal of Cardiology in 2014, Drs. Mohamad Alkhouli and Riyaz Bashir question the efficacy of the inferior vena cava (IVC) filter as a device for routine use and raise cautions about the apparent lack of retrieval of these temporary filters, particularly in U.S. patients. There is little doubt that in some cases, the IVC filter is a necessary device; however, the article’s authors expressed concern over “prophylactic” use of IVC filters in certain patient populations.

The IVC filter is a device designed to reduce the possibility of recurrent pulmonary embolism or PE, (blood clots reaching the heart and lungs) as well as fatalities caused by PE. The filters are manufactured by eleven companies and, when called for, are implanted in the inferior vena cava, the largest vein in the human body. The article’s authors state there is “only one randomized-controlled trial” that examined the efficacy of the IVC filter in accomplishing its primary purpose. This study, called PREPIC (Prevention du Risque d’Embolie Pulmonaire par Interruption Cave), showed that, while there was a reduction in PE occurrence, there was no impact on short- or long-term mortality. Worse, PREPIC showed a significant increase in the occurrence of deep-vein thrombosis (DVT). DVT is a condition in which a blood clot (thrombus) forms in one of the deeper veins, typically in the legs. If DVT occurs and the clot breaks loose, PE is a likely result and can be fatal.

Though there is a definite lack of data strongly supporting IVC filter use, Drs. Alkhouli and Bashir found that the use of IVC filters in the U.S. is on the rise. At the time of their writing, IVC filters were being used in 12% – 17% of patients with venous thromboembolism (VTE), a condition involving both DVT and PE, but used in over 40% of patients with a high risk of bleeding. One of the items the doctors found most intriguing was the fact that the implantation rates in patients with a high risk of bleeding was 25 times greater in the U.S. than in Europe. This is likely due to a lack of commonality among guidelines for IVC filter use.

The indications (or conditions calling for use) for IVC filters vary widely, even in the U.S. There are two types of indications: therapeutic and prophylactic. The most common indications are therapeutic and include:

DVT or PE and contraindication of anticoagulation therapies (reasons blood thinners should not be used)

Anticoagulation therapy failure

Massive PE

Severe cardiopulmonary (heart and lung) disease complicated by DVT.

Among the more controversial prophylactic uses of IVC filters are:

Preventing PE in patients having high-risk surgeries, such as bariatric or spinal procedures

Trauma victims without VTE

The problem, according to the authors, is that over half of IVC filter placements fall into the prophylactic category, despite one population-based study of 213 IVC filter patients. That study, conducted by a panel of thrombosis experts, showed that only 51% of those studied actually needed the IVC filter. The other 49% didn’t meet the requisite indications for such therapy. Further, there is a marked lack of agreed-upon definition of “contraindication to anticoagulation” therapy, as well as evidence that several patients who were implanted with an IVC filter due to contraindication to anticoagulation were, in face, on anticoagulation protocols.

One paper, referencing the RIETE registry (registry of patients with venous thromboembolism), stated that 60% of patients studied who were implanted with an IVC filter due to “relative or absolute contraindication to anticoagulation” were on some form of anticoagulant therapy. This further underscores the question of “true contraindications to anticoagulation.”

Perhaps the worst issue with IVC filters is the possibility of serious short- and long-term health complications due to their use. Such complications include:

Migration of the IVC filter, including to another blood vessel (called embolization)

Fracture of the filter

Penetration of the inferior vena cava by the filter

IVC perforation of the inferior vena cava

IVC thrombosis (a clot forming around the filter)

The main reason for these complications is late retrieval of the IVC filters. These devices were not meant to be permanent; rather, they are intended for use only until the risk of PE passes and then they are supposed to be removed. Drs. Alkhouli and Bashir cite research that shows “late filter-related thrombosis” occurred in 8% – 30% of cases studied.

The major problem with IVC filters in the U.S. is the poor rates of retrieval. At the time the authors wrote their article, the highest removal rate reported in the U.S. was 34%, compared to 81% in U.K. They found that some IVC filters aren’t removed for good reasons, such as a tilted filter or a trapped clot.

However, the most common reason they found for lack of removal was poor follow-up by implanting doctors. In the meantime, the IVC filters that remain in the body longer than recommended continue to put patients at risk of very serious health complications. This, even after the FDA issued two safety warnings (2010 & 2014) stating that implanting doctors should remove the IVC filters as soon as the risk of PE has passed.

In 2012 the Journal of the American Medical Association published an article titled “Frequent Fracture of TrapEase Inferior Vena Cava Filters,” providing further insight into one serious side effect related to the use of IVC filters. Inferior vena cava (IVC) filters are small metal filters placed within the vena cava vein used to trap blood clots, stopping them from reaching the lungs, where potentially fatal pulmonary embolism may result.

Dr. Masaki Sano led a team of researchers from the Hamamatsu School of Medicine (Hamamatsu, Japan) and studied 20 IVC filter patients, following up with x-ray imaging periodically in the months following emplacement.

“Thrombus inside the filter was detected in 2 cases. None of the patients presented filter-related life-threatening adverse events such as cardiac tamponade or retroperitoneal hematoma.”

Due to the fact that many IVC filter manufacturers repeatedly failed to warn users of these and other risk linked to IVC filters, IVC filter lawsuits have recently been filed in great number.

If you or a loved one used an IVC filter in the treatment of deep vein thrombosis and suffered an IVC filter fracture or perforation, IVC migration, or another IVC filter side effect, you may be entitled to significant financial compensation through an IVC filter lawsuit.

For a free, no-obligation case consultation, contact our team of IVC filter lawyers at Justinian PLLC. We have the compassion, experience, and resources required to win the compensation you deserve. Call today and find out how we can help.

In 2012, a team of researchers from the Department of Radiology and Biomedical Imaging at the University of California, San Francisco published an article that illustrated some serious risks associated with the use of IVC filters.

Inferior vena cava filters are small metal filters inserted into the inferior vena cava vein, used in patients with deep vein thrombosis (DVT) to mechanically catch blood clots before they can reach the lungs and cause in pulmonary embolism. Sometimes, these filters are implanted permanently, and sometimes IVC filters are implanted for a limited time, ranging from a few months to a year.

Unfortunately, IVC filters can prove difficult to remove, and research has shown that the longer an IVC filter stays in the inferior vena cava, the more likely it is to fail or cause dangerous side effects. IVC side effects can include perforation (tearing) of the IVC vein or internal organ, IVC fracture and embolization (wherein the IVC filter breaks and travels through the blood to the heart or lungs, resulting in myriad – potentially deadly – health problems), and both tilting and migration of the device.

Durack et al. (2012) found “Perforation of at least one filter component through the IVC was observed in 43 of 50 (86%) filters on CT scans obtained between 1 and 880 days after filter placement.”

“All filters imaged after 71 days showed some degree of vena caval perforation, often as a progressive process. Filter tilt was seen in 20 of 50 (40%) filters, and all tilted filters also demonstrated vena caval perforation.”

As such, researchers concluded that “Longer indwelling times usually result in vena caval perforation by retrievable Günther Tulip and Celect IVC filters” and noted that side effects “from IVC filter components breaching the vena cava can be significant.”

Because of the high rate of IVC complications, the team suggests “filter retrieval as early as clinically indicated and increased attention to the appearance of IVC filters on all follow-up imaging studies.”

Due to the fact that many IVC filter manufacturers have failed time and again to adequately warn users of these risks, many IVC lawsuits are currently being filed, including one multidistrict litigation.

If you or a loved one used an IVC filter and suffered an adverse outcome, you may be entitled to significant financial compensation. For a free, no-obligation IVC case consultation, contact our team of IVC lawyers at the information provided below.

We have the compassion, experience, and resources to win the compensation you deserve. Call today and see how we can help.

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled. This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus, where gradual bone distraction is required,” for children less than one year old.

However, the FDA writes that “Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.” (emphasis added)

Again according to the FDA, “DePuy Synthes is recalling certain lots because the device may reverse direction and lose the desired distraction distance after surgery”, noting that “children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.”

Importantly, it is made clear that “In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.”

To-date, fifteen people have been injured due to failure of the CMF Distraction System.

If you or a loved one used a CMF Distraction System and suffered injury as a result, you may be entitled to significant financial compensation through a CMF Distraction lawsuit. For a free, no-obligation case consultation, contact our team of CMF Distraction lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

One result of elevated metal ion levels in the blood can be pseudotumors. The team writes “The primary purpose of this study was to assess the prevalence of pseudotumor formation in asymptomatic patients with a metal-on-metal total hip replacement after a minimum duration of follow-up of two years. A secondary purpose was to assess whether a correlation exists between elevated serum metal ion levels and pseudotumor formation.”

Patients evaluated in this study included “thirty-one asymptomatic patients with a metal-on-metal total hip arthroplasty, twenty-four asymptomatic patients with a metal-on-polyethylene total hip arthroplasty, and twenty asymptomatic patients with a metal-on-metal hip resurfacing arthroplasty.”

Results showed that 32% of metal-on-metal hip replacement patients “had a solid or cystic mass, with another three patients (10%) having a substantial fluid collection.” Only 25% of hip resurfacing patients faced such ailments. And, “Pseudotumor formation was significantly more frequent in the metal-on-metal total hip arthroplasty group compared with the metal-on-polyethylene total hip arthroplasty group.”

As such, Williams et al. (2011) concluded that “We recommend high-resolution ultrasound surveillance of all asymptomatic patients with a metal-on-metal implant that is known to result in high serum metal ion levels. Once a metal-on-metal implant is known to be associated with high serum metal ions, the measurement of ion levels does not helpfully contribute to surveillance.”

Because DePuy, the manufacturer of many metal-on-metal hip replacement systems such as the recently-recalled ASR™ and DePuy ASR™ XL models, has failed time and time again to warn of these potential side effects, a number of ASR lawsuits have been filed.

If you or a loved one used a metal-on-metal hip replacement such as the ASR, you may be entitled to significant financial compensation. For a free, no-obligation case consultation, feel free to contact our team of DePuy ASR lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

The team states that “Plasma levels of cobalt and chromium ions and Metal Artefact Reduction Sequence (MARS)-MRI scans were performed on patients with 209 consecutive, unilateral, symptomatic metal-on-metal (MoM) hip arthroplasties.” So, this study is admittedly fairly small.

However, results were clear, showing that “scans were positive for adverse reaction to metal debris (ARMD) in 84 hips (40%)” and the team concluded that “Metal ion analysis is not recommended as a sole indirect screening test in the surveillance of symptomatic patients with a MoM arthroplasty. The investigating clinicians should have a low threshold for obtaining cross-sectional imaging in these patients, even in the presence of low plasma metal ion levels.”

Because DePuy, the company that makes many metal-on-metal hip replacement systems, has failed to adequately warn users of these risks, a number of DePuy ASR hip replacement lawsuits have been filed. If you or someone you know used the DePuy ASR or ASR XL metal hip replacement, you may be entitled to significant financial compensation. For a free, no-obligation case consultation, contact our team of ASR lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

The Register states that the FDA “is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device.”

For clarity, the FDA medical device classification system is based on safety and likelihood to perform intended device function. There are three classes in all: Class I contains items such as dental floss, Class II contains items such as condoms, and Class III contains items such as replacement heart valves. The proposal by the FDA to move vaginal mesh to a higher class indicates that the Agency finds vaginal mesh more dangerous than previously thought.

Because this research was published in widely-read journals, and vaginal mesh manufacturers failed to update warning labels or discontinue the product, a number of vaginal mesh lawsuits have been filed. Furthermore, writes Matthew Perrone of The Washington Post, “In February, U.S. District Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded that [Johnson and Johnson] destroyed thousands of documents regarding development of its pelvic-mesh implants, but said there was no proof that it was done intentionally. The documents would have included reports on patient testing of the mesh implants and could have shown whether participants suffered serious complications.”

As it currently stands, there are more than 20,000 vaginal mesh lawsuits pending against Johnson and Johnson alone, one of many vaginal mesh manufacturers.

If you or a loved one used transvaginal mesh and suffered complications or required surgery, you too may be eligible to file a transvaginal mesh lawsuit and gain significant financial compensation. For a free, no-obligation case consultation, contact our team of transvaginal mesh lawyers at the information provided below. We have the compassion, experience, and resources required to win the justice you deserve. Call today and see how we can help.

Johnson & Johnson (J&J) executives are currently under the microscope as to whether or not they engaged in criminal activity when they “lost” documents critical to lawsuits filed against them.

As we noted in previous posts, on February 4th, a federal magistrate judge ruled that Ethicon, a subsidiary of J&J, destroyed or lost documents that should have been preserved in anticipation of litigation involving its pelvic mesh devices. However, the judge also found that Ethicon’s loss of evidence was negligent, rather than willful or deliberate.

Nevertheless, advocates for women injured by J&J’s products recently urged the U.S. Department of Justice to investigate whether J&J actually did intentionally destroy the documents. Specifically, on March 26, 2014, a patient advocacy consumer group called, the Corporate Action Network, filed a complaint with the Department of Justice, asking Attorney General, Eric Holder, to investigate whether or not J&J executives engaged in criminal activity by destroying records in a federal probe. In its letter, the group stated:

“We respectfully request that you investigate Johnson and Johnson, Inc. and its top executives including Chairman and CEO, Alex Gorsky, for two possible criminal violations: first, for obstruction of a criminal investigation of health care offenses in apparent violation of 18 U.S.C. Section 1518 and second, for destruction of documents in apparent violation of 18 U.S.C. Section 1519. This request follows the recent discovery of document destruction by Johnson and Johnson as related to lawsuits brought against them by thousands of women across the United States who have been seriously injured by the corporation’s pelvic mesh implants.”

Essentially, advocates have pushed for a criminal investigation into whether J&J executives committed the crime of tampering with evidence, which includes knowingly destroying or altering documents “in contemplation of” an investigation or other proceeding by the federal government that may occur in the future. (18 U.S.C. § 1519.)

As we stated in one of our past articles entitled, Ethicon and its Faulty Pelvic Mesh Devices: Destroying Valentine’s Day…and Implicating Documents, we can only guess that the conveniently missing documents were ones that did not paint J&J in a good light. But whether J&J deliberately destroyed the documents, or lost them due to its own negligence, the outcome is the same: The documents are gone. And it’s to the plaintiffs’ detriment.

The Law Offices of Justinian Lane remain committed to helping women who have been severely injured by pelvic mesh devices. We continue to offer free consultations to prospective clients, so if you have been harmed by pelvic mesh, please contact our law firm for more information.

The surgeries evaluated in this study were 300 consecutive ones performed between June 2005 and October 2012 at a single center. The 300 patients were divided into two groups based on the time of surgery, to determine the learning curve of surgeons at Cedars-Sinai. There were 120 patients in the first, “initial” cohort, and 180 patients in the second, “recent” group.

Doctors write “Overall, 8 patients (2.7%) required subsequent mitral valve replacement via a median sternotomy” and “One patient in each group had mitral valve re-repair through a right mini-thoracotomy, and 1 patient in the first group required a mitral valve replacement via a mini-thoracotomy during the original procedure.”

The team continues “Follow-up echocardiography for the last 180 patients from 1 month to more than 1 year showed no/trace mitral regurgitation in 64.6% of patients and mild mitral regurgitation in 23.1% of patients. Seven patients (10.8%) had moderate mitral regurgitation, and 1 patient (1.5%) had severe mitral regurgitation.” That is, at least about 35% of patients faced mitral regurgitation after robot-assisted surgery — surgery that was intended to close the mitral valve failed and blood was allowed to flow through in the opposite direction (regurgitation).

Due to the fact that a high rate of complications is associated with robotic-assisted surgery, and manufacturers such as Da Vinci have failed to warn patients and doctors and require (not merely “recommend”) training before using their devices in a clinical setting, a number of robotic-assisted surgery lawsuits have been filed.

If you or a loved one underwent robotic-assisted surgery and suffered complications as a result, you may be entitled to significant financial compensation for your injuries. For a free, no-obligation case consultation, contact our team of surgical robots lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.